达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1250
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.701638431638281638001638941638561638440.03
212.781632521634451633480.09
单位质量响应值RSD%判断
12901.1012781.530.66数据可信
供试品溶液-25041501批-达格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1136754-13675468.49975.7511.2268.5075.7511.22
2143794-14379472.02672.03
3174082-17408287.19787.20
4160424-16042480.35580.36
5162187-16218781.23881.24
6130115-13011565.17465.17
10min1182862-18286291.59493.492.7691.7093.602.77
2182133-18213391.22991.34
3193796-19379697.07197.20
4191313-19131395.82895.95
5187950-18795094.14394.26
6181842-18184291.08491.18
15min1188354-18835494.34595.362.3194.5995.612.32
2187241-18724193.78894.03
3196990-19699098.67198.95
4194209-19420997.27897.54
5189964-18996495.15295.41
6185473-18547392.90293.14
20min1189310-18931094.82495.902.0495.2196.302.05
2188848-18884894.59394.98
3196105-19610598.22898.65
4196571-19657198.46198.87
5190448-19044895.39495.80
6187485-18748593.91094.28
30min1189922-18992295.13195.841.8095.6596.381.82
2189690-18969095.01595.54
3195825-19582598.08898.66
4195469-19546997.90998.47
5189595-18959594.96795.52
6187554-18755493.94594.46
45min1188820-18882094.57996.101.6095.2596.791.60
2191382-19138295.86296.53
3195641-19564197.99598.71
4195665-19566598.00798.71
5189518-18951894.92895.62
6190150-19015095.24595.90
60min1188737-18873794.53795.611.9595.3596.441.96
2190695-19069595.51896.33
3195375-19537597.86298.73
4195390-19539097.87098.72
5188459-18845994.39895.23
6186669-18666993.50194.30
120min1190544-19054495.44297.952.6196.3998.922.61
2197444-19744498.89999.86
3199765-199765100.061101.07
4202415-202415101.388102.39
5193016-19301696.68197.66
6190088-19008895.21496.15
180min1187303-18730393.81997.132.9994.9198.242.98
2196654-19665498.50399.61
3198278-19827899.316100.48
4201455-201455100.908102.06
5191815-19181596.07997.20
6187927-18792794.13295.21
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1185050-18505092.69096.673.4093.9297.943.39
2196120-19612098.23599.49
3197404-19740498.878100.19
4201407-201407100.884102.19
5192140-19214096.24297.51
6185907-18590793.12094.34
360min1182344-18234491.33595.663.6492.7197.073.62
2194698-19469897.52398.92
3195294-19529497.82299.28
4200232-200232100.295101.75
5188987-18898794.66296.07
6184353-18435392.34193.70
480min1180605-18060590.46494.913.7991.9796.473.78
2193533-19353396.94098.49
3194078-19407897.21398.82
4198871-19887199.613101.22
5187335-18733593.83595.39
6182517-18251791.42292.92
600min1179983-17998390.15294.213.7391.8095.903.71
2192187-19218796.26597.96
3192861-19286196.60398.36
4196954-19695498.653100.41
5185900-18590093.11694.81
6180563-18056390.44392.08
720min1178445-17844589.38293.473.8491.1695.303.82
2190696-19069695.51897.36
3191059-19105995.70097.60
4196235-19623598.293100.19
5183742-18374292.03593.87
6179428-17942889.87491.65
极限1178064-17806489.19193.323.8491.1195.303.82
2190906-19090695.62497.60
3189992-18999295.16697.21
4195852-19585298.101100.15
5184293-18429392.31194.28
6178728-17872889.52491.43
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数10
标示量(mg)1000供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 9.991155053115453011539101154556115311611542330.07
2 9.961151068114960411503360.09
单位质量响应值RSD%判断
115538.84115495.580.03数据可信
供试品溶液-25041501批-二甲双胍-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min140943-409433.5443.565.343.543.565.39
243095-430953.7313.73
342039-420393.6393.64
443041-430413.7263.73
540384-403843.4963.50
637239-372393.2243.22
10min1100584-1005848.7079.324.418.719.334.42
2103633-1036338.9718.98
3108672-1086729.4079.41
4111267-1112679.6329.64
5108635-1086359.4049.41
6113215-1132159.8019.81
15min1147731-14773112.78913.414.9112.8113.434.91
2153633-15363313.30013.32
3163313-16331314.13814.16
4161860-16186014.01214.03
5158256-15825613.70013.72
6144649-14464912.52212.54
20min1186535-18653516.14816.823.6916.1916.863.70
2193903-19390316.78616.82
3198129-19812917.15117.19
4203360-20336017.60417.65
5198633-19863317.19517.24
6185296-18529616.04116.08
30min1247943-24794321.46422.433.0321.5322.503.02
2260973-26097322.59222.66
3263659-26365922.82422.89
4267786-26778623.18123.25
5263225-26322522.78722.85
6251015-25101521.73021.79
45min1321776-32177627.85529.282.7027.9529.382.70
2345467-34546729.90630.00
3340896-34089629.51029.61
4346251-34625129.97430.08
5340542-34054229.48029.58
6334291-33429128.93929.03
60min1381913-38191333.06134.562.4633.2034.702.46
2403313-40331334.91435.06
3403561-40356134.93535.08
4409797-40979735.47535.62
5402376-40237634.83334.98
6394438-39443834.14534.28
120min1579924-57992450.20252.132.0150.3952.322.01
2607793-60779352.61552.81
3606091-60609152.46852.67
4615195-61519553.25653.46
5604670-60467052.34552.54
6599211-59921151.87252.06
180min1715369-71536961.92763.801.5762.1964.071.57
2743904-74390464.39864.67
3738579-73857963.93764.21
4748816-74881664.82365.10
5739633-73963364.02864.30
6735931-73593163.70763.97
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1818849-81884970.88572.801.5371.2473.161.54
2850797-85079773.65174.02
3843180-84318072.99273.36
4855838-85583874.08774.47
5839392-83939272.66473.03
6837458-83745872.49672.86
360min1972084-97208484.15185.411.0384.6185.881.03
2993904-99390486.03986.52
3982263-98226385.03285.51
41001397-100139786.68887.18
5985881-98588185.34585.82
6984118-98411885.19285.66
480min11065064-106506492.20093.060.9692.7993.670.96
21085203-108520393.94394.55
31066647-106664792.33792.95
41090300-109030094.38495.00
51072479-107247992.84193.45
61070672-107067292.68593.28
600min11117549-111754996.74396.830.8497.4797.570.84
21128970-112897097.73298.48
31107520-110752095.87596.62
41130551-113055197.86998.63
51114684-111468496.49597.24
61111847-111184796.24996.99
720min11134297-113429798.19398.150.9799.0699.040.96
21144823-114482399.104100.00
31118944-111894496.86497.76
41147829-114782999.364100.27
51127788-112778897.62998.52
61129240-112924097.75598.64
极限11133111-113311198.09098.241.2699.1199.281.26
21144177-114417799.048100.09
31114711-111471196.49797.53
41156795-1156795100.140101.20
51130580-113058097.87198.91
61129674-112967497.79398.82
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1250
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.701644601649241644721642091640641644260.20
212.781641431644661643040.14
单位质量响应值RSD%判断
12946.9312856.340.50数据可信
供试品溶液-25041502批-达格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min177031-7703138.40450.5513.9638.4050.5513.97
2107122-10712253.40553.41
399633-9963349.67249.67
4119077-11907759.36659.37
5108009-10800953.84853.85
697465-9746548.59148.59
10min1162774-16277481.15186.373.5281.2186.453.52
2174387-17438786.94087.02
3171607-17160785.55485.63
4180152-18015289.81489.90
5178053-17805388.76888.85
6172488-17248885.99386.07
15min1177105-17710588.29589.901.6788.4790.101.68
2180443-18044389.95990.17
3177575-17757588.53088.73
4184223-18422391.84492.07
5183523-18352391.49591.71
6179016-17901689.24889.45
20min1181172-18117290.32390.741.5090.6391.081.50
2181705-18170590.58990.93
3178820-17882089.15089.49
4184145-18414591.80592.17
5186204-18620492.83293.18
6180035-18003589.75690.09
30min1187019-18701993.23891.271.9993.6991.741.98
2182163-18216390.81791.30
3178829-17882989.15589.62
4183001-18300191.23591.73
5187629-18762993.54294.03
6179758-17975889.61890.09
45min1184297-18429791.88191.071.8192.4791.681.81
2183874-18387491.67092.29
3179525-17952589.50290.10
4182163-18216390.81791.45
5187565-18756593.51094.14
6178628-17862889.05589.66
60min1183922-18392291.69491.122.1292.4291.862.11
2184329-18432991.89792.65
3181963-18196390.71791.45
4181353-18135390.41391.19
5188347-18834793.90094.67
6176664-17666488.07588.81
120min1190277-19027794.86293.422.8295.7294.302.80
2189996-18999694.72295.61
3185542-18554292.50293.37
4184918-18491892.19093.10
5194296-19429696.86697.78
6179230-17923089.35590.23
180min1188307-18830793.88092.673.3894.8893.703.36
2189570-18957094.51095.54
3184484-18448491.97492.99
4182729-18272991.09992.15
5194189-19418996.81297.87
6176052-17605287.77088.77
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1186724-18672493.09192.203.7194.2493.363.69
2189441-18944194.44595.62
3184561-18456192.01293.16
4182084-18208490.77891.96
5193386-19338696.41297.61
6173439-17343986.46887.60
360min1185808-18580892.63491.463.9393.9292.763.90
2188215-18821593.83495.15
3183452-18345291.46092.75
4181006-18100690.24091.56
5191418-19141895.43196.78
6170757-17075785.13186.40
480min1183029-18302991.24990.764.1292.6792.204.08
2186953-18695393.20594.66
3182818-18281891.14392.57
4178527-17852789.00490.46
5191400-19140095.42296.91
6169616-16961684.56285.96
600min1181982-18198290.72790.124.3992.2991.704.35
2186043-18604392.75194.35
3180784-18078490.12991.69
4177708-17770888.59690.18
5190675-19067595.06196.69
6167457-16745783.48585.01
720min1180859-18085990.16789.384.3491.8691.104.30
2184225-18422591.84593.58
3179606-17960689.54291.24
4176345-17634587.91689.64
5188723-18872394.08795.86
6165965-16596582.74184.39
极限1178920-17892089.20088.894.1291.0390.744.09
2183043-18304391.25693.13
3179273-17927389.37691.21
4175909-17590987.69989.55
5187121-18712193.28995.21
6165577-16557782.54884.32
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数10
标示量(mg)1000供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 9.991155899115680111557281155794115335611555160.12
2 9.961151760115465311532060.18
单位质量响应值RSD%判断
115667.27115783.730.08数据可信
供试品溶液-25041502批-二甲双胍-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135974-359743.1093.255.063.113.255.11
238829-388293.3553.36
337942-379423.2793.28
438214-382143.3023.30
534755-347553.0033.00
639903-399033.4483.45
10min187857-878577.5928.585.797.608.585.78
2102340-1023408.8438.85
3100807-1008078.7118.72
4103409-1034098.9368.94
599427-994278.5928.60
6101709-1017098.7898.79
15min1137213-13721311.85713.034.5611.8713.054.56
2151029-15102913.05113.07
3152692-15269213.19413.21
4155119-15511913.40413.42
5155605-15560513.44613.46
6153233-15323313.24113.26
20min1177441-17744115.33316.563.7415.3716.593.73
2192504-19250416.63516.67
3193927-19392716.75816.80
4197600-19760017.07517.11
5193213-19321316.69616.73
6194853-19485316.83816.88
30min1249559-24955921.56522.462.1521.6222.522.16
2259407-25940722.41622.48
3259693-25969322.44022.50
4265435-26543522.93723.00
5261499-26149922.59622.66
6263774-26377422.79322.86
45min1318947-31894727.56129.212.8727.6529.312.88
2340198-34019829.39729.49
3337807-33780729.19029.29
4344710-34471029.78729.89
5342437-34243729.59029.69
6344115-34411529.73529.83
60min1382777-38277733.07635.143.1333.2135.283.12
2406463-40646335.12335.26
3420804-42080436.36236.50
4411729-41172935.57835.72
5409684-40968435.40135.54
6408237-40823735.27635.42
120min1584858-58485850.53852.732.3650.7252.922.36
2613847-61384753.04353.24
3602083-60208352.02752.22
4619475-61947553.53053.73
5622588-62258853.79953.99
6618432-61843253.44053.63
180min1730243-73024363.10164.931.9863.3665.211.98
2760405-76040565.70865.98
3735591-73559163.56363.84
4757936-75793665.49465.77
5767171-76717166.29266.57
6757356-75735665.44465.72
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1843468-84346872.88574.201.5973.2474.571.59
2858829-85882974.21374.58
3841663-84166372.72973.10
4868417-86841775.04175.42
5875255-87525575.63276.01
6864706-86470674.72075.09
360min11007911-100791187.09587.431.1587.5587.911.15
21006879-100687987.00687.49
3992897-99289785.79886.27
41020319-102031988.16788.65
51024381-102438188.51889.01
61018156-101815687.98088.47
480min11112582-111258296.14095.951.3496.7396.561.34
21102673-110267395.28495.90
31084698-108469893.73094.34
41115850-111585096.42297.04
51126703-112670397.36097.98
61119676-111967696.75397.37
600min11177533-1177533101.752100.681.44102.49101.441.43
21155544-115554499.852100.61
31136526-113652698.20998.96
41170235-1170235101.122101.89
51182563-1182563102.187102.95
61168233-1168233100.949101.71
720min11200672-1200672103.752102.451.33104.64103.361.32
21171737-1171737101.251102.16
31161817-1161817100.394101.29
41191682-1191682102.975103.89
51199961-1199961103.690104.61
61187761-1187761102.636103.55
极限11191883-1191883102.992102.071.18104.04103.131.18
21166761-1166761100.821101.88
31160592-1160592100.288101.33
41188031-1188031102.659103.73
51192823-1192823103.074104.15
61187144-1187144102.583103.65
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